EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
FDA Launches Web-Based Tobacco Premarket Application Forms to Enhance Submission Process
The FDA’s Center for Tobacco Products (CTP) has introduced new web-based versions of key forms used for PMTA and Substantial Equivalence (SE) Report submissions. These updated forms are now available through CTP Portal Next Generation (NextGen), the agency’s enhanced portal for electronic tobacco...
Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)
The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.
21 CFR Part 11 (Electronic Records & Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated, or “GxP” computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA’s 21 CFR Part 11 was enacted in 1997 and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic, or system of record.
FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
The U.S. Food and Drug Administration has announced a significant expansion of its internal artificial intelligence capabilities through the deployment of agentic AI tools across the agency. The new system is designed to help FDA staff manage complex, multi-step tasks more efficiently while...
Current Food Production Methods
By Lane Highbarger, EAS Consulting Group Independent ConsultantThe past 50 years of research in microbiological pathways have taught us much about genes and the resultant protein products. The discovery of restriction enzymes in the 1970s and the ‘simple’ enzymatic-cut-and-paste of genes that...
2026 Computer System Validation (CSV) Series
Computer System Validation (CSV) SeriesPurchase individually or all as oneEmerging FDA Trends in Computer System Validation (CSV)Presented by Carolyn Troiano, EAS Independent ConsultantFebruary 11, 2026Data Integrity and Governance for Computer Systems Regulated by FDAPresented by Carolyn Troiano,...
Drug and Device Corner 2025 November
For those not already aware, the US government shutdown has ended. The User Fee system is now open and accepting FY2026 payments.The first step for renewal of your Medical Device facility is to pay the FDA FY2026 Medical Device Annual Establishment Registration User Fee of $11,423. This process...
Validation & Use of FDA-Regulated Systems Using AI, ML & Large Language Models (LLMs), such as ChatGPT
The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen some trends toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations that have more recently begun to be used more heavily in life science companies.
Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT are beginning to find a presence at these companies. While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much more activity related to AI use in software applications used to develop, produce, test, and manage life science products with quality and compliance.
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where artificial intelligence (AI) and machine learning (ML) are becoming prevalent.
FDA became alarmed by the lack of compliance to meet data integrity and Part 11 requirements during the last decade. Out of compliance citations during this period, including Form 483s and Warning Letters have skyrocketed for these key areas of compliance. But why?
Based on discussions with clients and stakeholders at conferences and meetings, it has become more and more obvious that most of the performers in industry are under management pressure to do more work with fewer resources and in less time. This continues to lead performers to seek faster and easier ways to get the work done, and opens the door to more conversation around the use of AI/ML in software development, testing, and support.
Data Integrity and Governance for Computer Systems Regulated by FDA
During this webinar, we will focus on the importance of ensuring that both structured (e.g., database records) and unstructured (e.g., Word document, PDF, spreadsheet) data are maintained with integrity through their chronological life cycle. This requires recognition that FDA is laser-focused on data integrity issues based on industry inspection trends during the past decade.
FDA’s Guidance for Data Integrity, issued in December 2018, did not include a single new requirement. Instead, it reiterated parts of the Code of Federal Regulations (CFRs) that have been in place for decades, and which industry was failing to meet.
Emerging FDA Trends in Computer System Validation (CSV)
The life science industries, including pharmaceutical, medical device, biotechnology, biological, tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA.
We have seen the recent trend in industry toward using cloud-based services, Software-as-a-Service (SaaS) solutions, and other technical innovations. More recently, we have begun to see newer, emerging technologies including Artificial Intelligence (AI), Machine Learning (ML) algorithms & Large Language Models (LLMs), such as ChatGPT begin to find a presence within these companies.
While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much greater use of AI in the development, testing, release & management of life science products with quality and compliance. This is most predominant in the medical device industry, where we find both medical devices that include software as a product component & Software-as-a-Medical-Device (SaMD) products that function as a medical device without the need for any hardware.
How to Respond to an FDA Inspection (483)
Now that the FDA has issued your firm a 483 or Warning Letter, what to do next? This webinar will cover the expectations and requirements of the FDA for responding to inspectional findings, best practices, and tips for creating a comprehensive response, including corrective and preventive actions taken and planned to address the observations.
Preparing for an FDA Inspection
Be prepared when (not if) the FDA is at your doorstep for an inspection! This webinar will cover the processes and procedures to have in place to handle any regulatory inspections at your facility, and the set ups, best practices, and tips for personnel throughout the inspection process, ensuring that the inspection goes as smoothly as possible.
FSVP Tips to Navigate Common Pitfalls
By Brandon Boone, EAS Consulting Group Independent ConsultantSince the implementation of the FDA’s Foreign Supplier Verification Program (FSVP) in 2017, overall compliance rates have remained consistently low. There are a wide range of compliance levels—from firms that received Warning Letters to...
Drug and Device Corner 2025 October
REMINDER: We are in the drug registration renewal and listing certification period, do schedule your renewal/certification prior to the 31 December 2025 deadline. Facilities that manufacture OTC monograph drugs are reminded that the data pulled for assessing FY2026 OMUFA user fees are based on...
Update October 23, 2025 – Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications
Constituent Update FDA Human Foods Program October 23, 2025 Read on FDA WebsiteDue to the lapse in appropriations, FDA is postponing the virtual public meeting on November 18, 2025, and listening sessions on November 19 - 20, 2025 regarding food allergen thresholds and their potential applications...
Medical Device QMSR (ISO 13485)
Presented by Jeb HunterDecember 15, 2025 | 1 PM EasternIn January of 2024, 21 CFR 820 was harmonized with ISO 13485 into the Quality Management System Regulation (QMSR), a regulation that better aligns the processes and requirements for a medical device facility with international standards...
Drug and Device Corner 2025 September
REMINDER: The drug and medical device establishment registration renewal and listing certification period begins 1 October 2025. EAS is here to assist our clients with this process, do not hesitate to reach out if you need support.The agency has published their final guidance document “Alternative...
Health Canada
Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada.
FDA Announces First Use of Import Certification Authority for Certain Shrimp and Spices Potentially Contaminated with Cesium-137
October 3, 2025 Constituent Update Read on FDA WebsiteThe FDA announced today that, effective October 31, 2025, the agency will require import certification for shrimp and spices from certain regions of Indonesia, based on the risk of potential contamination of the food with Cesium-137. This...
How Do I Prevent Getting on an FDA Red List?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business. These disruptions lead to lost time, spoiled shipments, and unhappy customers. But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
USDA’s Process for Auditing Equivalent Foreign Food Safety Systems
The United States Department of Agriculture (USDA), through its Food Safety and Inspection Service (FSIS), is responsible for ensuring that imported meat, poultry, and processed egg products meet the same safety standards as those produced domestically. To achieve this, FSIS’s State and International Audit Staff (SIAS) regularly audits food safety inspection systems of foreign countries deemed equivalent to the United States (U.S.).
A Guide to FSMA 204
A Guide to FSMA 204: Sorting Through the Confusion of the FDA’s New Traceability Rule for Added Food SafetyPresented by Tim Lombardo and Thomas BellSeptember 24, 2025, 1pm (eastern)The final Food Safety Modernization Act rule, the Food Traceability Rule – commonly referred to as FSMA 204 – will...
How Do I Get Removed from an FDA Red List?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
HHS, FDA and USDA Extend Comment Period for Data and Information on Ultra-Processed Foods
September 18, 2025 Constituent Update Read on FDA WebsiteThe U.S. Food and Drug Administration and the U.S. Department of Agriculture are extending the comment period by 30 days for the Request for Information on ultra-processed foods. On July 24, 2025, the FDA and USDA issued a joint Request for...
Shelly Blackwell interviewed for NutraIngredients USA
Shelly Blackwell, Senior Director for Dietary Supplement and Tobacco Consulting Services at EAS Consulting Group, provided timely and practical insights in her recent interview with NutraIngredients-USA. Speaking with Danielle Masterson at the RSQ Conference, Blackwell highlighted the growing...
FDA Expert Panel on Food Allergies
The FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action. This initiative is part of the FDA’s...
What Do I Need to Know About My Testing Lab?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
FDA issues final guidance on using remote oversight tools to help approve drugs
FDA has issued a final guidance on how the agency intends to use alternative tools in advance, in lieu of, or in support of preapproval and prelicense inspections to remotely evaluate drug manufacturing facilities named in pending applications as part of FDA’s drug review process. FDA uses a...
FDA Detained My Product – Now What?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
Heads-up: Front-of-Pack labels, GRAS changes, and supplement definition update
FDA has signaled three significant rulemakings in the Unified Agenda that could affect food and dietary supplement companies. These are not official final rules—but they’re far enough along that your regulatory, R&D, and labeling teams may want to prepare.1) Front-of-Package (FOP) Nutrition...